A Study to Evaluate the Real-world Usage and Effectiveness of Elocta and Alprolix in Patients With Haemophilia A or B (PREVENT)

October 1, 2024 updated by: Swedish Orphan Biovitrum

A 24-month Prospective, Non-interventional, Multicentre Study to Evaluate the Real-World Usage and Effectiveness of Elocta and Alprolix in Patients With Haemophilia A or B

Elocta (rFVIIIFc) and Alprolix (rFIXFc) are recombinant extended half-life coagulation factor products. The purpose of this non-interventional study is to describe the real-world usage and effectiveness of Elocta and Alprolix in the prophylactic treatment of haemophilia A and B.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

201

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany
        • Swedish Orphan Biovitrum Reserach site
      • Blaubeuren, Germany
        • Swedish Orphan Biovitrum Reserach site
      • Bonn, Germany
        • Swedish Orphan Biovitrum Research site
      • Delmenhorst, Germany
        • Swedish Orphan Biovitrum Research site
      • Duisburg, Germany
        • Swedish Orphan Biovitrum Research site
      • Erlangen, Germany
        • Swedish Orphan Biovitrum Reserach site
      • Frankfurt, Germany
        • Swedish Orphan Biovitrum Research site
      • Frankfurt, Germany
        • Swedish Orphan Biovitrum Reserach site
      • Fürth, Germany
        • Swedish Orphan Biovitrum Research site
      • Hamburg, Germany
        • Swedish Orphan Biovitrum Research site
      • Hannover, Germany
        • Swedish Orphan Biovitrum Research site
      • Hannover, Germany
        • Swedish Orphan Biovitrum Reserach site
      • Heidelberg, Germany
        • Swedish Orphan Biovitrum Reserach site
      • Homburg, Germany
        • Swedish Orphan Biovitrum Reserach site
      • Jena, Germany
        • Swedish Orphan Biovitrum Research site
      • Jena, Germany
        • Swedish Orphan Biovitrum Reserach site
      • Leipzig, Germany
        • Swedish Orphan Biovitrum Reserach site
      • Mörfelden-Walldorf, Germany
        • Swedish Orphan Biovitrum Reserach site
      • München, Germany
        • Swedish Orphan Biovitrum Research site
      • München, Germany
        • Swedish Orphan Biovitrum Reserach site
      • Münster, Germany
        • Swedish Orphan Biovitrum Reserach site
      • Würzburg, Germany
        • Swedish Orphan Biovitrum Research site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All eligible Elocta and Alprolix patients who present for a routine Clinical visit will be asked to participate in the study by the treating physician at participating haemophilia treatment centres in Germany.

Description

Inclusion Criteria:

  • Have a diagnosis of haemophilia A or B and previously treated with factor Product
  • Have started prophylactic Elocta/Alprolix treatment prior to enrollment visit, or at enrollment prescribed prophylactic treatment with Elocta or Alprolix regardless of participation in the study
  • Signed and dated informed consent provided by the patient, or the patient's legally acceptable representative for patients under the legal age, Before any study-related activities are undertaken. Assent should be obtained from paediatric patients according to local regulations.

Exclusion Criteria:

  • Participation in an investigational medicinal product trial, from four weeks prior to first injection with Elocta or Alprolix to enrollment visit.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Haemophilia A patients
Elocta will be prescribed according to local practice and administered by patients with haemophilia A for prophylactic treatment
Drug: ELOCTA
Extended half-life factor VIII product
Other Names:
  • Eloctate, efmoroctocog alfa, rFVIIIFc
Haemophilia B patients
Alprolix will be prescribed according to local practice and administered by patients with haemophilia B for prophylactic treatment
Drug: ALPROLIX
Extended half-life factor IX product
Other Names:
  • Eftrenonacog alfa, rFIXFc

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Annualised injection frequency
Time Frame: 24 months
Assessed by prescription
24 months
Annualised bleeding rate (ABR)
Time Frame: 24 months
Based on bleeding episodes assessed by local practice
24 months
Annualised factor consumption (IU)
Time Frame: 24 months
Assessed by dispensed factor product
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Swedish Orphan Biovitrum

Investigators

  • Study Director: Study Physician, MD, Swedish Orphan Biovitrum

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 9, 2017

Primary Completion (Actual)

April 19, 2022

Study Completion (Actual)

April 19, 2022

Study Registration Dates

First Submitted

February 14, 2017

First Submitted That Met QC Criteria

February 15, 2017

First Posted (Actual)

February 16, 2017

Study Record Updates

Last Update Posted (Actual)

October 2, 2024

Last Update Submitted That Met QC Criteria

October 1, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Sobi.HAEM89-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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